US9775887B2 - Enzyme formulation for reducing salicylate intolerance - Google Patents

Enzyme formulation for reducing salicylate intolerance Download PDF

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Publication number
US9775887B2
US9775887B2 US14/967,746 US201514967746A US9775887B2 US 9775887 B2 US9775887 B2 US 9775887B2 US 201514967746 A US201514967746 A US 201514967746A US 9775887 B2 US9775887 B2 US 9775887B2
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formulation
symptoms
chymotrypsin
salicylate
migraines
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US20170165329A1 (en
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Thea Fournier
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Priority to EP16876422.3A priority patent/EP3390647A4/en
Priority to CA3007374A priority patent/CA3007374A1/en
Priority to PCT/US2016/065813 priority patent/WO2017106036A1/en
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Priority to US15/698,820 priority patent/US10195256B2/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4826—Trypsin (3.4.21.4) Chymotrypsin (3.4.21.1)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4866—Protein C (3.4.21.69)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/03—Phosphoric monoester hydrolases (3.1.3)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01026—Beta-fructofuranosidase (3.2.1.26), i.e. invertase
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01108—Lactase (3.2.1.108)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21001—Chymotrypsin (3.4.21.1)

Definitions

  • Salicylates are compounds that are manufactured synthetically and found in artificial colorings and flavorings, solvents, many personal care products and elsewhere in some foods as additives/preservatives. These salicylate compounds are also naturally occurring in many plant foods, including fruits, vegetables, and herbs/spices. In the course of many years of consulting and observing thousands of clients, the inventor has found that patients who follow the recommended dietary restrictions (which reduce or substantially eliminate salicylates), experience a significant improvement in a wide range of symptoms and pathologies.
  • Eliminating salicylates and adhering to the recommendations appears to be highly effective in treating a wide range of symptoms/conditions, including, but not limited to: stuttering, migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD), atrial fibrillation, anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy.
  • stuttering migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD), atrial fibrillation, anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy.
  • Beta Glucanase has been found to be effective in treating salicylate intolerant people, and causing a significant improvement in a wide variety of symptoms/conditions, including, but not limited to: stuttering, migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD), atrial fibrillation, anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy. It is believed that the formulation catalyzes breakdown of salicylate compounds in vivo.
  • the preferred dosages of the enzymes in the formulation are as follows: Beta Glucanase: 200 BGU; Chymotrypsin (from porcine, preferably, or beef) 3.0 mg (and not less than 3000 USP units); Phytase 30 FTU; Lactase 600 ALU, and Invertase 600 INVU. More preferred, is ingesting two or more of the formulation with the foregoing contents with each meal.
  • a preferred carrier for the formulation is a vegetable capsule (including, mostly cellulose and distilled water). Most preferred is that the formulation be free of any of the following: casein, gluten, dairy, egg, soy, corn, peanuts, tree nuts, and fish.
  • the preferred dosages of the enzymes set forth in the Summary are not the only dosages possible, and other more optimal dosages and dosing regimes may be discovered with routine experimentation, now that the preferred dosages are known.
  • the routine experimentation would involve providing different dosages under different regimes, using behavioral kinesiology to determine the appropriate dosage and optimal regime for each individual child or adult in the case study, and determining which patients improved most in their monitored diseases and conditions.
  • the starting point for determining optimal dosing and an optimal regime is the preferred dosages, administered once a day, as above. Variations could be doubling, halving, or otherwise and reducing the quantities of one or more of the enzymes in a formulation.
  • the dosing regime modifications could include increasing or reducing the number of administrations of the formulation each day for patients in a particular group. Such experimentation is routine in the pharmaceutical industry.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nutrition Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Disclosed is a formulation of the following enzymes: Beta Glucanase, Chymotrypsin, Phytase, Lactase, and Invertase, which has been found to be effective in treating salicylate intolerant people, and causing a significant improvement in a wide variety of pathologies and symptoms, including, but not limited to: stuttering, migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD), atrial fibrillation, anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy.

Description

BACKGROUND
Many people suffer from food intolerance. It is believed that many such people's intolerances can be traced to use of pesticides, and/or genetically engineered foods, which adversely affect liver pathways, inhibit enzymes, and disrupt amino acids in the body which ultimately can lead to food intolerances.
Intolerance to gluten has been widely discussed. Less well known, but equally widespread, is intolerance to salicylates and histamines. Salicylates are compounds that are manufactured synthetically and found in artificial colorings and flavorings, solvents, many personal care products and elsewhere in some foods as additives/preservatives. These salicylate compounds are also naturally occurring in many plant foods, including fruits, vegetables, and herbs/spices. In the course of many years of consulting and observing thousands of clients, the inventor has found that patients who follow the recommended dietary restrictions (which reduce or substantially eliminate salicylates), experience a significant improvement in a wide range of symptoms and pathologies. Eliminating salicylates and adhering to the recommendations, appears to be highly effective in treating a wide range of symptoms/conditions, including, but not limited to: stuttering, migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD), atrial fibrillation, anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy.
SUMMARY
A formulation of the following enzymes: Beta Glucanase, Chymotrypsin, Phytase, Lactase, and Invertase, has been found to be effective in treating salicylate intolerant people, and causing a significant improvement in a wide variety of symptoms/conditions, including, but not limited to: stuttering, migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD), atrial fibrillation, anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy. It is believed that the formulation catalyzes breakdown of salicylate compounds in vivo.
More particularly, the preferred dosages of the enzymes in the formulation are as follows: Beta Glucanase: 200 BGU; Chymotrypsin (from porcine, preferably, or beef) 3.0 mg (and not less than 3000 USP units); Phytase 30 FTU; Lactase 600 ALU, and Invertase 600 INVU. More preferred, is ingesting two or more of the formulation with the foregoing contents with each meal. A preferred carrier for the formulation is a vegetable capsule (including, mostly cellulose and distilled water). Most preferred is that the formulation be free of any of the following: casein, gluten, dairy, egg, soy, corn, peanuts, tree nuts, and fish.
A discussion of testing and demonstrating the safety and efficacy of the formulation is set forth below in the Detailed Description.
DETAILED DESCRIPTION
It has been found over decades of study, that people who adopt a dietary restriction plan which eliminates foods and food products containing salicylates experience significant improvement in some, but not limited to, the following symptoms and conditions: stuttering, migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD), atrial fibrillation, anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy. The formulation will be administered to two groups of patients in order to test its treatment effects.
Group/Branch One:
After baseline symptom information has been collected, patients in group one will remove salicylates 100% from their daily diet for two months. After the two months, they will fill out the form again checking symptoms they are experiencing and severity of them. The Formulation will then be administered to each patient who has experienced significant improvement in those symptoms/conditions. After three weeks on the formulation, patients will begin consuming salicylate containing food. Their symptoms will be monitored bi-weekly for two months. As a result of being on the Formulation, it will be determined if they can successfully eat salicylates without a recurrence of adverse symptoms, if there is increased improvement, or if symptoms worsen.
Group/Branch Two:
Salicylate intolerant patients in group two will remove no salicylates from their daily diet. Eligible patients will be randomly assigned to receive the Formulation (n=25) or Placebo (n=25) after eligibility is established and baseline symptoms and severity of symptoms have been assessed. Over a two month period of follow-up, patients symptoms and conditions will be monitored at monthly visits. All primary analyses will be based on the intention-to-treat principle. Formulation and placebo groups will be compared and proof of efficacy would be a statistically significant improvement in one or more of the foregoing of symptoms or conditions. Statistically significant differences at the alpha 0.05 level will be reported.
The preferred dosages of the enzymes set forth in the Summary are not the only dosages possible, and other more optimal dosages and dosing regimes may be discovered with routine experimentation, now that the preferred dosages are known. The routine experimentation would involve providing different dosages under different regimes, using behavioral kinesiology to determine the appropriate dosage and optimal regime for each individual child or adult in the case study, and determining which patients improved most in their monitored diseases and conditions.
The starting point for determining optimal dosing and an optimal regime, is the preferred dosages, administered once a day, as above. Variations could be doubling, halving, or otherwise and reducing the quantities of one or more of the enzymes in a formulation. The dosing regime modifications could include increasing or reducing the number of administrations of the formulation each day for patients in a particular group. Such experimentation is routine in the pharmaceutical industry.
The terms and expressions that have been employed are used as terms of description and not of limitation, and there is no intent in the use of such terms and expressions to exclude any equivalent of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention as claimed. Thus, it will be understood that although the present invention has been specifically disclosed by preferred embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims.

Claims (5)

What is claimed is:
1. A method for treating symptoms of one or more of the following diseases or conditions: stuttering, diabetes-associated neuropathy, migraines, ADHD, Tourette's disease, seizures, autism and atrial fibrillation, comprising administering a formulation consisting essentially of the enzymes: Beta Glucanase, Chymotrypsin, Phytase, Lactase and Invertase.
2. The method of claim 1 wherein the quantities of the enzymes in the formulation are: Beta Glucanase, 200 BGU; Chymotrypsin, not less than 3000 USP units; Phytase 30 FTU; Lactase 600 ALU and Invertase 600 INVU.
3. The method of claim 2 wherein the Chymotrypsin is derived from porcine or beef and the quantity is 3.0 mg.
4. The method of claim 1 wherein the diseases or conditions are ADHD and migraines.
5. The method of claim 1 wherein the formulation is administered at least once per day.
US14/967,746 2015-12-14 2015-12-14 Enzyme formulation for reducing salicylate intolerance Active US9775887B2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
US14/967,746 US9775887B2 (en) 2015-12-14 2015-12-14 Enzyme formulation for reducing salicylate intolerance
EP16876422.3A EP3390647A4 (en) 2015-12-14 2016-12-09 Enzyme formulation for reducing salicylate and other intolerance
CA3007374A CA3007374A1 (en) 2015-12-14 2016-12-09 Enzyme formulation for reducing salicylate and other intolerance
PCT/US2016/065813 WO2017106036A1 (en) 2015-12-14 2016-12-09 Enzyme formulation for reducing salicylate and other intolerance
US15/698,820 US10195256B2 (en) 2015-12-14 2017-09-08 Enzyme formulation for reducing salicylate and other intolerance

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Application Number Priority Date Filing Date Title
US14/967,746 US9775887B2 (en) 2015-12-14 2015-12-14 Enzyme formulation for reducing salicylate intolerance

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US9775887B2 true US9775887B2 (en) 2017-10-03

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EP (1) EP3390647A4 (en)
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10195256B2 (en) * 2015-12-14 2019-02-05 Thea Fournier Enzyme formulation for reducing salicylate and other intolerance

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060115467A1 (en) * 2004-12-01 2006-06-01 Pangborn Jon B Compositions and methods for the treatment of autism
US20070116695A1 (en) * 2005-09-21 2007-05-24 Fallon Joan M Pharmaceutical preparations for attention deficit disorder, attention deficit hyperactivity disorder and other associated disorders
US20080199448A1 (en) * 2007-02-16 2008-08-21 Ross Mairi R Enzyme composition for improving food digestion
US9056050B2 (en) * 2009-04-13 2015-06-16 Curemark Llc Enzyme delivery systems and methods of preparation and use
US20170000830A1 (en) * 2015-07-01 2017-01-05 Rakesh Saini Compositions for Relieving the Symptoms of Gluten Sensitivity and Methods of Use Thereof

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
Dr. Tennant's Digest Enzyme Formula product page, Supplement Facts, Jun. 2014. *
Hare L. et al. Dietary Salicylates. J Clinical Path 56:649-650, 2003. *
Houston Enzymes Newsletter. The Enzyme Digest Issue 35, Sep. 2010, pp. 1-4. *
Houston Enzymes No-Fenol product page, supplement facts. *
http://www.kirmangroup.com/phenol-assist-enzyme.html Product page for Phenol Assist(TM) unknown date. *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10195256B2 (en) * 2015-12-14 2019-02-05 Thea Fournier Enzyme formulation for reducing salicylate and other intolerance

Also Published As

Publication number Publication date
EP3390647A1 (en) 2018-10-24
US20170165329A1 (en) 2017-06-15
EP3390647A4 (en) 2019-08-21
WO2017106036A1 (en) 2017-06-22
CA3007374A1 (en) 2017-06-22

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